Bachelor's degree in chemical, mechanical, biomedical, industrial, or related engineering discipline.
5+ years of process engineering experience, specifically in EO sterilization processes.
Proven ability to analyze process data and implement sustainable improvements.
Strong project management and technical writing skills.
Experience with ISO 11135 and sterilization quality requirements preferred.
Familiarity with Lean Six Sigma methods and statistical analysis preferred.
Experience with chamber controls and capital expansion projects preferred.
Responsibilities
Serve as a technical resource for EO sterilization processes and equipment.
Lead improvements in cycle consistency and operating efficiency while maintaining validated requirements.
Monitor and trend key process parameters to identify variations and recommend improvements.
Develop and optimize sterilization cycles in collaboration with Quality and technical resources.
Investigate cycle deviations and lead root cause analysis for process interruptions.
Evaluate proposed changes through approved change control and assess validation impact.
Support capital projects and improve equipment reliability through collaboration with Maintenance.
Benefits
Opportunity for professional development and technical training.
Collaborative work environment with cross-functional teams.
Engagement in impactful projects related to sterilization processes.
Access to advanced engineering tools and technologies.
Commitment to safety and adherence to environmental standards.
Full Job Description
Purpose:
The purpose of this document is to define the responsibilities and qualifications of the Engineering Manager - Ethylene Oxide Sterilization at ETO in Columbia, Alabama. This position provides technical leadership for EO sterilization processes, cycle development, validation support, process improvement, and equipment reliability.
Equipment:
EO sterilization chambers, preconditioning and aeration systems, process monitoring and control systems, instrumentation, and related engineering tools and software.
Responsibilities:
Process Engineering and Optimization:
Serve as a technical resource for EO sterilization, including preconditioning, chamber processing, aeration, and related equipment and controls.
Lead improvements in cycle consistency, throughput, capacity utilization, and operating efficiency while maintaining validated process requirements.
Monitor and trend temperature, humidity, pressure, EO delivery or concentration, exposure time, and aeration performance to identify variation and recommend improvements.
Cycle Development and Validation:
Develop and optimize sterilization cycles with Quality, customers, and technical resources; evaluate product and load configurations, process parameters, and acceptance criteria.
Prepare and execute engineering studies and support equipment qualification, sterilization validation, requalification, and process performance assessments.
Prepare protocols, analyze study results, and write technical reports in accordance with approved procedures.
Troubleshooting and Corrective Action:
Investigate cycle deviations, process interruptions, and equipment performance issues; lead root cause analysis and support corrective and preventive actions.
Partner with Operations, Quality, Maintenance, and equipment suppliers to troubleshoot instrumentation, sensors, vacuum systems, controls, and related equipment.
Change Control and Technical Documentation:
Evaluate proposed changes to equipment, software, process parameters, load configurations, and procedures through approved change control, including assessment of validation impact.
Prepare and maintain process specifications, engineering documentation, standard operating procedures, and technical training materials.
Equipment Reliability and Capital Projects:
Work with Maintenance to improve equipment reliability and support calibration and preventive maintenance strategies for critical process equipment.
Support capital projects and facility expansion through capacity analysis, equipment specifications, technical evaluations, installation support, commissioning, and startup.
Manage assigned engineering projects, schedules, and technical deliverables.
Safety and Technical Support:
Work with Environmental, Health and Safety on process risk assessments, safe operating practices, and engineering improvements related to EO handling, exposure prevention, and emissions control.
Provide technical support for customer inquiries, audits, and inspections within assigned approval authority.
Train and coach employees on process requirements and troubleshooting; provide technical direction and mentoring.
Perform other related duties as assigned.
Qualifications/ Education:
Bachelor's degree in chemical, mechanical, biomedical, industrial, or a related engineering discipline.
Experience analyzing process data, investigating deviations, identifying root causes, and implementing sustainable improvements.
Five or more years of relevant process engineering experience, cycle development, validation, or technical process support. Direct experience with EO sterilization processes is required.
Experience analyzing process data, investigating deviations, identifying root causes, and implementing sustainable improvements.
Ability to interpret process flow diagrams, piping and instrumentation diagrams, equipment specifications, and technical reports.
Strong project management, technical writing, communication, and cross functional collaboration skills; ability to manage priorities and work independently.
Experience in contract sterilization or medical device manufacturing and familiarity with ISO 11135 and related sterilization quality requirements preferred.
Experience with biological indicators, product and load families, aeration studies, and EO residual considerations preferred.
Experience with statistical analysis, design of experiments, process capability studies, or Lean Six Sigma methods preferred.
Experience with chamber controls, data acquisition systems, equipment commissioning, or capital expansion projects preferred.
Physical Demands:
Ability to work in office and industrial sterilization environments, including periods of sitting, standing, and walking.
Ability to access equipment areas and climb stairs or platforms as required.
Ability to use computers, engineering tools, and related equipment.
Ability to bend, stoop, kneel, or crouch as needed to inspect equipment and processes.
Ability to review process data, instrumentation displays, drawings, and technical documents.
Ability to use required personal protective equipment and follow site access and safety requirements.
Essential functions may be performed with reasonable accommodation.
Work environment:
Work is performed in office and controlled industrial sterilization environments and requires adherence to site safety procedures and personal protective equipment requirements.
Occasional support outside normal business hours may be required for process issues, validation activities, or equipment startup.
